Pear Therapeutics, Inc., the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its reSET-A™ PDT product candidate designed for the treatment of alcohol use disorder (AUD).
reSET-A potentially expands Pear’s addiction franchise, which includes FDA-authorized products to treat substance use disorder (SUD) and opioid use disorder (OUD). This is the second such Breakthrough Device Designation received by Pear, following the designation awarded for reSET-O®, the first ever for a PDT, which was for the treatment of OUD.
Alcohol is one of the most commonly used substances in the United States. AUD is a clinical diagnosis of alcoholism, or alcohol addiction characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences1. According to a national survey, approximately 14 million adults ages 18 and older in the U.S. had AUD in 2019 with fewer than one in 10 individuals with a 12-month diagnosis of AUD receiving any treatment2,3.
Each year, an estimated 95,000 people die from alcohol-related causes, making alcohol the third-leading preventable cause of death in the United States4 with an estimated total annual medical cost in hospitals of $7.6 billion5. Today, there are few treatment options for patients with AUD with less than 2% of patients with AUD receiving medication for treating AUD6. In the U.S. today, there are no FDA-authorized medical devices or PDTs indicated for people suffering from AUD-only7.
We believe that PDTs can bring effective, evidence-based treatments for alcohol use disorder to many more people and in doing so help address the public health burden of AUD, said Yuri Maricich, Pear’s Chief Medical Officer. We applaud FDA for recognizing the need to bring safe, effective, and innovative treatment options to patients and clinicians and we look forward to working closely with FDA under the Breakthrough Devices Program to gain marketing authorization of our AUD-only PDT product candidate.
The Breakthrough Devices Program is intended for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is designed to expedite development of the device and the prioritized review of the subsequent regulatory submissions, although there is no assurance that any of these benefits may be experienced.
It is available for devices, like PDTs, which may be subject to FDA review under a premarket approval (PMA) application, premarket notification (510(k)), or De Novo classification request.
Pear’s AUD-only PDT product candidate, reSET-A, has not received marketing authorization from FDA and is not available for sale in the United States.
- National Institute on Alcohol Abuse and Alcoholism. (2021). Alcohol Facts and Statistics.
- Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Behavioral Health Statistics and Quality. 2019 National Survey on Drug Use and Health. Table 5.4A—Alcohol Use Disorder in Past Year Among Persons Aged 12 or Older, by Age Group and Demographic Characteristics: Numbers in Thousands, 2018 and 2019. https://www.samhsa.gov/data/sites/default/files/reports/rpt29394/NSDUHDetailedTabs2019/NSDUHDetTabsSect5pe2019.htm?s=5.4&#tab5-4a. Accessed September 29, 2021.
- https://www.psychiatry.org/newsroom/news-releases/apa-releases-new-practice-guideline-on-treatment-of-alcohol-use-disorder Accessed September 29, 2021.
- Centers for Disease Control and Prevention (CDC). Alcohol and Public Health: Alcohol-Related Disease Impact (ARDI). Annual Average for United States 2011–2015 Alcohol-Attributable Deaths Due to Excessive Alcohol Use, All Ages. Available at: https://nccd.cdc.gov/DPH_ARDI. Accessed September 29, 2021 Methodology: According to CDC, due to scientific updates to ARDI, estimates of alcohol-attributable deaths or years of potential life lost generated in the current version of ARDI should not be compared with estimates that were generated using the ARDI default reports or analyses in the ARDI Custom Data Portal prior to July 30, 2020.
- Peterson C, Li M, Xu L, Mikosz CA, Luo F. Assessment of Annual Cost of Substance Use Disorder in US Hospitals. JAMA Netw Open.2021;4(3):e210242. doi:10.1001/jamanetworkopen.2021.0242.
- reSET, Pear’s PDT, for patients with substance use disorder, includes in its labeled indications patients who use alcohol as well as other substances, such as cannabis, cocaine, or stimulants like methamphetamines
- Han et al. 2021.
- Campbell ANC, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.
- Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.